BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 15073608 · Received July 21, 2022

    Report

    Report Number
    9610614-2022-00023
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    July 4, 2022
    Report Date
    July 21, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR THE DEVICE. A REVIEW OF THE CHRONOLOGICAL DATA IN THE SYSTEM REVEALED THAT THE PROCEDURAL SETTINGS WERE HIGH CUT MODE, EFFECT 4 AND SWIFT COAG MODE, EFFECT 5. IN ADDITION, NO ERRORING OR PRODUCT ISSUES WERE RECORDED. FINALLY, NO ANOMALIES WERE FOUND IN THE REVIEW OF THE UNIT'S DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. UPON REVIEWING THE REPORTED EVENT, IT APPEARS THAT USER ERROR CAUSED OF THE EVENT. SPECIFICALLY, ACCORDING TO THE USER, THE ELECTROSURGICAL HANDLE WAS PLACED IN A NON-INSULATED AND CONDUCTIVE METAL MOUNTED CONTAINER. WHEN THE INSTRUMENT WAS INADVERTENTLY ACTIVATED, THERE WAS A TRANSFER OF ELECTRICAL CURRENT/HEAT WHICH MELTED THE COVERING AND CAUSED THE PATIENT BURN. ERBE'S USER MANUAL FOR THE ELECTROSURGICAL UNIT EXPLICITLY STATES THAT INSTRUMENTS MUST BE PLACED IN A SAFE PLACE: STERILE, DRY, NON-CONDUCTIVE AND CLEARLY VISIBLE. STORED INSTRUMENTS MUST NOT COME INTO CONTACT WITH THE PATIENT, THE MEDICAL STAFF AND COMBUSTIBLE MATERIALS. INSTRUMENTS THAT HAVE BEEN PUT DOWN MUST NOT TOUCH THE PATIENT INDIRECTLY. AN INSTRUMENT CAN TOUCH THE PATIENT INDIRECTLY, E.G. VIA ELECTRICALLY CONDUCTIVE OBJECTS OR WET CLOTHS. THE PATIENT EVENT COULD HAVE BEEN AVOIDED IF THE USER FOLLOWED THE INSTRUCTIONS IN THE MANUAL. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR). THE INCIDENT OCCURRED DURING AN IMPLANTATION OF A KNEE PROSTHESIS. THE ESU WAS USED WITH AN ERBE SMOKE EVACUATION HANDLE [PART NUMBER (P/N) 20321-060, LOT NUMBER (L/N) 02109010]. ADDITIONALLY, A MEGADYNE (P/N: 0845, SERIAL NUMBER: (B)(4) NEUTRAL ELECTRODE WAS ON THE PATIENT'S BACK. THEN, THE SURGICAL AREA (THIGH AND LOWER LEG) WAS COVERED WITH A THIN PLASTIC SHEET (3M¿ LOBAN¿ 2, P/N 6648EU ANTIMICROBIAL INCISION DRAPE, 56CM X 60CM) [NOTE: THE COVERING IS IMPREGNATED WITH BETAISODONA TO ACT AS A PROTECTIVE BACTERIAL BARRIER.]. WHEN LIFTING THE PATIENT'S LEG, THE HANDLE'S ACTIVE ELECTRODE WAS INADVERTENTLY ACTIVATED WHICH MELTED THE SHEET AND BURNED THE PATIENT. THE BURN/NECROSIS WAS ON THE FRONT OF THE PATIENT'S THIGH (ABOVE THE SURGICAL SITE) AND WAS 2 CM2 IN SIZE. IT WAS WHITISH IN APPEARANCE AND CLASSIFIED AS A 3RD DEGREE BURN. UPON HEALING, ADDITIONAL SURGERY MAY BE REQUIRED TO ADDRESS THE BURN/NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698786 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other